An interventional study of Multiple central venous lines in two sites separately and Multiple central venous lines in one site (internal jugular vein) in Central Venous Catheters, Catheter Complications and Catheter Related Complication, sponsored by Hospital Nossa Senhora da Conceicao. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-20.
Sponsored by Hospital Nossa Senhora da Conceicao · Not applicable, Interventional, and Treatment
Patients at risk of significant intraoperative blood loss and/or potential hemodynamic instability often necessitate the placement of two or more central venous catheters, including large bore catheters. In tertiary hospitals, anesthesiologists frequently encounter patients undergoing major surgeries such as liver transplantation, lung transplantation, cardiac surgery, and vascular surgery, who require multiple central venous punctures as part of routine anesthetic management. However, most review and consensus articles do not directly address the utilization of multiple catheters in the same venous site, nor establish formal recommendations regarding this practice. The latest consensus on central venous access from the American Association of Anesthesiologists (ASA), published in 2012, briefly touches upon some aspects related to this practice but does not outline any contraindications. Thus, the investigators have identified a gap in evidence and robust prospective studies addressing the use of more than one catheter in the same site for central venous access. This lacuna underscores the importance of conducting a controlled clinical study in our institutions to establish the efficacy and safety of this approach in the perioperative context. The present study aims to evaluate the incidence of mechanical complications (such as dysrhythmias, arterial puncture, hematoma, pneumothorax/hemothorax, insertion failure, or inadequate positioning) within the first 24 hours after double puncture of the internal jugular vein compared to puncture of two distinct central vessels, in patients undergoing multiple central venous accesses during major surgeries. This study will be designed as a prospective, randomized, non-inferiority, open, parallel clinical trial with two groups for patient allocation. Patients identified for multiple central venous accesses as part of preoperative anesthetic planning will be randomly allocated to either receive two central venous accesses in two separate sites (Group I or control group) or two concurrent central venous accesses in a single internal jugular vein (Group II or intervention group). Only adult patients classified as ASA I to IV (over 18 years old), scheduled for major surgery, will be eligible for inclusion.
Patients at risk of significant intraoperative blood loss and/or potential hemodynamic instability often necessitate the placement of two or more central venous catheters, including large bore catheters. In tertiary hospitals, we frequently encounter patients undergoing major surgeries such as liver transplantation, lung transplantation, cardiac surgery, and vascular surgery, who require multiple central venous punctures as part of routine anesthetic management. However, most review and consensus articles do not directly address the utilization of multiple catheters in the same venous site, nor do they establish formal recommendations regarding this practice. The latest consensus on central venous access from the American Association of Anesthesiologists (ASA), published in 2012, briefly touches upon some aspects related to this practice but does not outline any contraindications. This consensus primarily references the only comparative and prospective study conducted by Reeves and colleagues in 1995, which compared the passage of multiple central venous catheters in a single site (right internal jugular vein) with placements in different sites.
Thus, the investigators have identified a gap in evidence and robust prospective studies addressing the use of more than one catheter in the same site for central venous access. This lacuna underscores the importance of conducting a controlled clinical study in our institutions to establish the efficacy and safety of this approach in the perioperative context.
Our study aims to evaluate the incidence of mechanical complications (such as dysrhythmias, arterial puncture, hematoma, pneumothorax/hemothorax, insertion failure, or inadequate positioning) within the first 24 hours after double puncture of the internal jugular vein compared to puncture of two distinct central vessels, in patients undergoing multiple central venous accesses during major surgeries.
The study will be designed as a prospective, randomized, non-inferiority, open, parallel clinical trial with two groups for patient allocation. Patients identified for multiple central venous accesses as part of preoperative anesthetic planning will be randomly allocated to either receive two central venous accesses in two separate sites (Group I or control group) or two concurrent central venous accesses in a single internal jugular vein (Group II or intervention group). The preferred site for the second central venous access in Group I will be the subclavian vein.
Only adult patients classified as ASA I to IV (over 18 years old), scheduled for major surgery, will be eligible for inclusion. Surgical procedures considered for patient allocation include cardiac surgeries, vascular surgeries, major abdominal or thoracic surgeries, liver transplants, and lung transplants. Inclusion criteria specify patients with anesthetic planning for the insertion of at least two central venous catheters.
The primary hypothesis of this study is that the incidence of mechanical complications (cardiac arrhythmias, arterial puncture, hematoma, pneumothorax/hemothorax, catheter insertion failure or inadequate catheter positioning) is equivalent with two punctures in the internal jugular vein when compared to punctures in two different central vessels (internal jugular vein and subclavian and/or femoral vein).
The secondary hypotheses of this study are that the incidence of catheter-related infection, catheter malfunction, and puncture site thrombosis is lower with two punctures in the internal jugular vein when compared to punctures in two different central vessels (internal jugular vein and subclavian and/or femoral).
The study will be designed as a prospective, randomized, non-inferiority, open, parallel clinical trial with two groups for patient allocation. Patients who, according to preoperative anesthetic planning, have indications for multiple central venous accesses (i.e., patients with indications for 2 concomitant central venous catheters) will be randomly allocated to two central venous accesses in two sites separately ( Group I or control group) or two concomitant central venous accesses in a single internal jugular vein (Group II or intervention group). The preferred site for the second group I central venous access is the subclavian.
In this study, adult patients scheduled to undergo major surgery at the Hospital de Clínicas de Porto Alegre, Santa Casa de Porto Alegre and Hospital Nossa Senhora da Conceição will be included. All hospitals involved will have equivalent importance, varying participation according to the number of surgeries performed in the institutions.
Only adult ASA I to IV patients (over 18 years old), scheduled to undergo major surgery in the aforementioned hospitals, will be included.
The surgical procedures considered in this study for patient allocation include: cardiac surgeries, vascular surgeries, major abdominal or thoracic surgeries, liver transplants and lung transplants. Only patients with anesthetic planning for insertion of at least two central venous catheters will be included.
Hospital Nossa Senhora da Conceicao is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Multiple central venous lines in two sites separately
Procedure: Multiple central venous lines in two sites separately
Multiple central venous lines in a single internal jugular vein
Procedure: Multiple central venous lines in one site (internal jugular vein)
Patients with two central venous lines in two sites separately (two central venous sites).
Patients with two concomitant central venous lines in a single internal jugular vein (one central venous site).
Incidence of composite mechanical complications
The main outcome is to evaluate the incidence of mechanical complications (dysrhythmias, arterial puncture, hematoma, pneumothorax/hemothorax, insertion failure or inadequate positioning) in the first 24 hours after double puncture of the internal jugular vein compared to puncture of two distinct central vessels, in patients undergoing more than one central venous access in major surgeries.
Time frame: Intraoperative
Incidence of catheter-related infection
To evaluate the incidence of catheter-related infection (central line-associated bloodstream infections - CLABSI) after double puncture of the internal jugular vein compared to puncture of two distinct central vessels, in patients undergoing more than one central venous access in surgery. large.
Time frame: Up to 30 days after surgery
Incidence of central venous catheter malfunction
To evaluate the incidence of central venous catheter malfunction after double puncture of the internal jugular vein compared to the puncture of two different central vessels, in patients undergoing more than one central venous access in major surgeries.
Time frame: Up to 30 days after surgery
Insertion time of a central venous catheter
To evaluate the insertion time of a central venous catheter after double puncture of the internal jugular vein compared to the puncture of two different central vessels, in patients undergoing more than one central venous access in major surgeries.
Time frame: Intraoperative (during central venous line insertion)
Number of attempts to pass each catheter
To evaluate the number of attempts to pass each catheter after double puncture of the internal jugular vein compared to the puncture of two different central vessels, in patients undergoing more than one central venous access in major surgeries.
Time frame: Intraoperative (during central venous line insertion)
Incidence of venous thrombosis within 30 days
To evaluate the incidence of venous thrombosis within 30 days related to double puncture of the internal jugular vein compared to puncture of two different central vessels, in patients undergoing more than one central venous access in major surgeries.
Time frame: Up to 30 days after surgery
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2024; primary completion for Oct 2027, 39 months later.
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This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Hospital Nossa Senhora da Conceicao